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How Do I Perform Computer System Validation?
The FDA offers a guidance document (a document which describes
the FDA’s current thinking on a topic, but which is not law).
General Principles of Software Validation; Final Guidance for Industry and FDA
Staff, Issued 11 January 2002 by the FDA Center for Devices and Radiological
Health: Applicable to the validation of medical device software or the validation
of software used to design, develop, or manufacture medical devices. Based on
generally recognized software validation principles and, therefore, can be applied
to any software. No final guidance documents issued by CDER or CBER.
Outlines a Validation Life Cycle similar to a Software Development Life Cycle:
“[Customers] should develop a validation life cycle model that is appropriate for
their computer systems and organization.” Validation activities will be governed
by a customer’s Corporate Quality System Policy, Corporate Validation Policy,
System Implementation Policy, etc.